Biologic Abatement and Capturing Kids’ Outcomes and Flare Frequency in Juvenile Spondyloarthriti s (BACK-OFF JSpA)

Study Updated 03/05/2024

Study Website: The BACK-OFF JSpA Study
ClinicalTrials.gov#: NCT04891640
Study Design: Interventional
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Pamela Weiss
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2020
Study Duration: 2021 – 2025
Participating Clinical Research Networks: GPC, PaTH, PEDSnet, STAR
Therapeutic Area: Auto Immune
Condition: Juvenile Spondyloarthritis
Population: 8 Years to 21 Years (Child,  Adult)
Status: Recruiting

Research Question(s):

This trial will compare how patients with inactive spondyloarthritis on tumor necrosis factor inhibitor (TNFi) treatment respond to three treatment options that doctors currently use:

  • Continue standard TNFi medication,
  • Space out the time between usual TNFi medication doses, or
  • Stop the TNFi medication. If we can safely prolong the time between doses or completely take away TNFi therapy in this population, we may remove unnecessary medication exposure, improve patient quality of life, and lower medication costs.

Pediatric KIDney Stone (PKIDS) Care Improvement Network

Study Updated 03/05/2024

Study Website: Pediatric KIDney Stone (PKIDS) Care Improvement Network
ClinicalTrials.gov#: NCT04285658
Study Design: Prospective Observational
PCORnet Infrastructure: Collaboration, CDM (+supplemental data), Engagement, Single IRB
Principal Investigator: Gregory E. Tasian
Site Name: The Children’s Hospital of Philadelphia
PCORnet® Network Partner: PEDSnet
Funder: Patient-Centered Outcomes Research Institute (PCORI); (Project webpage)
Funding Date: 2019
Study Duration: 2020 – 2024
Participating Clinical Research Networks: GPC, OneFlorida+, PaTH, PEDSnet, STAR
Therapeutic Area: Renal
Condition: Kidney Stone; Nephrolithiasis
Population: 8 Years to 21 Years (Child, Adult)
Status: Active, not recruiting

Research Question(s):
What are the differences in stone clearance and the lived experiences of youth, age 8-21 years, following ureteroscopy (URS), shock wave lithotripsy (SWL), and percutaneous nephrolithotomy (PCNL) for the removal of kidney and ureteral stones?

Primary Publication(s):
Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial
Ellison JS, Lorenzo M, Beck H on behalf of the Pediatric KIDney Stone Care Improvement Network, et al. Comparative effectiveness of paediatric kidney stone surgery (the PKIDS trial): study protocol for a patient-centred pragmatic clinical trial. BMJ Open 2022;12:e056789. doi: 10.1136/bmjopen-2021-056789